MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM SYSTEM; FLUID JET REMOVAL SYSTEM

Catalog Number 220501

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: the aquabeam scope was returned for investigation.Visual inspection confirmed that the scope broke in two (2) places, and a portion was not returned for investigation.The break was consistent with resistance translating the scope at the proximal end of the travel, causing the scope to buckle and break.A review of the cpu log file for this procedure was performed, which showed that the scope was retracted to the proximal position at 13:08:56 minutes.The scope did not reappear on the cpu screen.At 13:09:24 minutes the handpiece was removed from the patient and undocked from the motorpack.The cpu log file showed that the procedure was aborted.The scope is a purchased device, which passed receiving inspection.A review of the device history record (dhr) was performed and no anomalies were observed.The review indicated that the device met all required specifications when released for distribution.A review for similar complaints was performed on lot number 18c00997, which confirmed no other similar event have been reported on this lot.Similar events have been reported across other lots; however, in neither of the events the procedures were aborted.The aquabeam robotic system's instructions for use, ifu320301, revision d.Was reviewed and in the trus probe and aquabeam handpiece insertion section states: using the scope carriage, retract the aquabeam scope to sphincter and then advance scope proximal (towards the bladder neck), so that the scope tip adequately covers and protects the sphincter.However, the ifu did not include precautionary instructions if excessive resistance was encountered during repositioning of the aquabeam scope, which may have resulted in a damaged aquabeam scope.The reported event was confirmed during investigation of the returned aquabeam scope.The break was consistent with encountering resistance to translating the scope carriage at the proximal end of travel, causing the scope to buckle and break.The aquabeam robotic system's ifu are being updated to include the following statement: "precaution: if excessive resistance is encountered during aquabeam scope positioning, reposition the aquabeam handpiece to minimize tenting the prostate in order to reduce the chance of damaging the aquabeam scope." submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

It was reported that during an aquablation procedure, the physician experienced tension through the patient anatomy's resulting in the aquabeam scope breaking off inside the aquabeam handpiece.The aquabeam scope and aquabeam handpiece were removed and the physician aborted the case.There was no patient adverse health consequences as a result of the event.The physician decided to perform a bipolar transurethal resection of the prostate (turp) to treat the enlarged patient's prostate.

Manufacturer Narrative

For corrected data, please refer to section h.1 type of reportable event, follow-up #1 was incorrectly submitted as "serious injury".

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• MDR Report Key: 9351302
• MDR Text Key: 167557672
• Report Number: 3012977056-2019-00053
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 220501
• Device Lot Number: 18C00997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1